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MCT and Capsaicin Provocation Challenge in Diagnosis of Chronic Cough

NCT03363698 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 55

Last updated 2021-06-11

No results posted yet for this study

Summary

The aim of the study is to assess the prevalence of bronchial hyperresponsiveness (BHR) in non-smoking adults with chronic cough and the prevalence of BHR in patients with upper airway cough syndrome (UACS) and gastroesophageal reflux disease (GERD), to evaluate the relationship between BHR and cough reflex sensitivity, to assess the diagnostic accuracy of methacholine challenge test (MCT) in cough variant asthma (CVA) with special regard to its discriminating cut off value between CVA and other causes of chronic cough, particularly GERD, to estimate prognostic value of BHR, fractional exhaled nitric oxide (FeNO) and induced sputum eosinophil count in predicting response to asthma treatment.

Patients diagnosed with a chronic cough will undergo the standard diagnostic work-up recommended by experts for patients with a chronic cough, including methacholine challenge test (MCT) and an at least 4-week period of causal treatment. Patients with BHR in MCT will be treated with - in first step B2-agonist and inhaled corticosteroid (ICS) for at least 4 weeks, if improvement is not significant in next steps with leukotriene receptor antagonist (LTRA) or systemic corticosteroid. A good treatment response, evaluated by visual analogue scale (VAS), Leicester Cough Questionnaire (LCQ) and cough challenge will confirm the diagnosis of the disease. A statistical analysis will consist of the frequency of BHR in a chronic cough, correlation between the results of MCT and cough reflex sensitivity in capsaicin inhalation test and cut-off point for MCT to discriminate asthma from other causes of a chronic cough.

Conditions

  • Cough
  • Cough Variant Asthma
  • Upper-Airway Cough Syndrome
  • GERD
  • Allergic Rhinitis

Interventions

OTHER

Cough variant asthma treatment

Evaluation of the treatment response to inhaled corticosteroids, long-acting beta-agonists, montelukast, prednisone.

Sponsors & Collaborators

  • Medical University of Warsaw

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-31
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03363698 on ClinicalTrials.gov